Table 4.
Population | Size, n | Injuries, n | Mean risk (CI) | Relative risk (CI) | P-value |
---|---|---|---|---|---|
Total | 710 | 102 | 0.14 (0.12–0.17) | ||
Sex | |||||
Male | 154 | 23 | 0.15 (0.10–0.21) | 1.05 (0.68–1.61) | 0.82 |
Female | 556 | 79 | 0.14 (0.12–0.17) | ||
Age | |||||
<Median | 346 | 51 | 0.15 (0.11–0.19) | 1.05 (0.74–1.51) | 0.39 |
>Median | 364 | 51 | 0.14 (0.11–0.18) | ||
Population type | |||||
Bifascicular block | 37 | 10 | 0.27 (0.15–0.43) | 1.98 (1.13–3.47) | 0.018 |
Vasovagal | 673 | 92 | 0.14 (0.11–0.17) | ||
Prior year, n | |||||
<Median | 74 | 16 | 0.22 (0.14–0.32) | 1.60 (0.99–2.57) | 0.027 |
>Median | 636 | 86 | 0.14 (0.11–0.16) | ||
Prodrome | |||||
Absent | 116 | 29 | 0.25 (0.18–0.34) | 1.60 (0.91–2.81) | 0.10 |
Present | 96 | 15 | 0.16 (0.10–0.24) | ||
Drug therapy | |||||
Placebo | 360 | 59 | 0.16 (0.13–0.21) | ||
Active | 313 | 33 | 0.11 (0.08–0.15) | 0.64 (0.43–0.96) | 0.015 |
Device therapy | |||||
ILR | 11 | 5 | 0.40 (1.1–10.2) | ||
Pacemaker | 10 | 4 | 0.45 (1.6–11.7) | 1.1 (0.42–3.1) | 0.8 |
Size, n is the number of faints. Injured, n is the number of faints resulting in an injury. The mean age in the total study population was 45 and the median number of faints in the year before randomization was 3. Prodromal symptoms were recorded in POST 3 and 4. The bifascicular heart block population was in POST 3 and the vasovagal population was in POST 2 and 4.
CI, confidence interval; ILR, implantable loop recorder.